Engineering Support Specialist
101 Orchard Ridge Dr North Potomac, MD 20878 US
Target Pay Rate: 30-47.85/hr **salary will be commensurate with experience
The candidate will work with combination products and the associated life-cycle maintenance activities. This includes Design Transfers, Periodic Risk Review Reports, Design History File (DHF) Remediation and commercial manufacturing support. Activities may include:
- Performing gap assessments on existing DHFs against SOPs and standards
- Updating relevant documents within the DHF
- Performing impact assessments for design changes
- Managing Change Controls and driving the implementation of the necessary activities for the change
- Analyzing complaints and compiling relevant data for the annual risk review
- Working with different functions such as; device development, device quality, drug product, packaging, and human factors
This position is located in the Drug Product Combination Product Global Technical Operations group located in Gaithersburg, MD. Working remotely is possible.
Position Qualifications (Preferred):
- Technical background in engineering (Bsc.)
- Experience with combination product LCM and design controls
- Experience in biotech/pharmaceutical or medical device company
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.